Sonoma Valley Hospital District

Summary Statement of Deficiencies D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(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 surveyor's review of the American Proficiency Institute (API) proficiency testing (PT) records, nine randomly chosen patient reports, and interviews with the laboratory manager (LM) and technical consultant (TC); it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for the high sensitivity C-Reactive protein (hs-CRP) analyte. The findings include: 1. The laboratory participated in the API PT program and obtained an unsatisfactory score of 0% for the hs-CRP analyte during the first event of 2025 (Q1-2025). The results are as follows: Specimen Reported Expected HS-01 *0.560 0.000 - 0.159 HS-02 *3.827 0.273 - 0.509 HS-03 *6.400 0.456 - 0.848 HS-04 *1.773 0.087 - 0.288 HS-05 *6.603 0.456 - 0.849 Legend: * = unsatisfactory score 2. The LM and TC affirmed by interviews on October 16, 2025, at approximately 11:00 a.m. that the laboratory received the unsatisfactory PT scores for hs-CRP analyte as mentioned in statement#1. 3. The quality and reliability of patient results reported cannot be assured. 4. According to the testing declaration form submitted at the time of survey, the laboratory tested and reported approximately 1,336 hs-CRP test patient samples annually including the time when unsatisfactory scores were obtained. . D2109 TOXICOLOGY CFR(s): 493.845(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 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 -- event. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing (PT) results, and interviews with the laboratory manager (LM) and technical consultant (TC); it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for the salicylate analyte for the second event of 2025 (Q2-2025) obtaining an unsatisfactory performance. The findings include: 1. The laboratory performed salicylate, an analyte under Toxicology subspecialty. 2. The laboratory enrolled its proficiency testing program with API PT program and received a 40% unsatisfactory score for the Q2-2025 event for the salicylate analyte. The result as follows: Sample Reported Expected CH-06 8.0 5.8 - 8.0 CH-07 32.0 24.2 - 32.8 CH-08 *17.0 12.3 - 16.7 CH-09 *26.0 18.9 - 25.7 CH-10 *45.0 31.9 - 43.2 Legend: * = unsatisfactory score 3. The laboratory performed salicylate in approximately 191 patient samples annually. 4. The LM and TC affirmed by interviews on October 16, 2025, at approximately 11:00 a.m. that the laboratory attained a score of 40% for the salicylate analyte in the Q2-2025 Toxicology PT event, which was an unsatisfactory performance. . 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 nine randomly chosen patient records, lack of personnel competency documentation, and interviews with the laboratory manager (LM) and technical consultant (TC); as specified in the personnel requirements in subpart M, it was determined that the laboratory failed to perform competency assessment for the personnel involved in patient testing. The findings include: 1. The surveyor reviewed nine randomly chosen patient records wherein, three testing personnel were missing competency assessment records, affecting five out of nine. 2. The quality and reliability of patient samples processed and reported could not be assured. 3. The LM and TC stated in interviews on October 16, 2025, at approximately 3:45 p.m. that several of their testing personnel lacked records for competency assessments for the years 2023, 2024, and 2025. 4. According to the testing declaration form (Lab-144) submitted at the time of the survey, the laboratory reported and performed approximately 446, 928 patient samples annually, including the time when competency assessments for several testing personnel were missed. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) (d)(3)(i) Each quantitative procedure, include two control materials of different concentrations; This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual, nine randomly -- 2 of 4 -- chosen patient testing records, lack of quality control documentation, and interviews with the laboratory manager (LM) and technical consultant (TC); the laboratory failed to retain all levels of quantitative quality control (QC) for each day of patient testing. The findings include: 1. The surveyor reviewed nine patient records and one out of nine was missing the quality control documentation for review. 2. The LM and TC affirmed by interviews on October 16, 2025, at approximately 3:45 p.m. that the laboratory was unable to obtain past records for the complete blood count quality control, specifically for September 28, 2022. 3. According to the testing declaration form submitted at the time of survey, the laboratory performed and reported approximately 118,527 complete blood count tests including the time when records were not properly retained. D5789 TEST RECORDS CFR(s): 493.1283(b) (b) Records of patient testing including, if applicable, instrument printouts, must be retained. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's policy/procedure, nine patient records, preventive maintenance (PM) records, and interviews with the laboratory manager (LM) and technical consultant (TC); it was determined that the laboratory failed to retain test records. The findings include: 1. The laboratory's current practice involved the use of an electronic medical record (EMR) system that kept final reports but still retained the original reports printed from the instrument as well as the hadcopies of the PM performed. 2. The surveyor examined nine patient records, but one record could not be retrieved by the laboratory for the original test result and PM, specifically for Patient#082197 on March 10, 2022. 3. The LM and TC affirmed by interviews on October 16, 2025, at approximately 3:45 p.m., that the records for the patient and instrument PM mentioned in statement #2 were unavailable. 4. According to the testing declaration submitted at the time of survey, the laboratory processed and reported approximately 118,111 complete blood count patient samples annually including the time when the records of the patient and instrument PM were not retained properly. The quality and reliability of patient tests reported cannot be assured. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on the surveyor's review of the unsatisfactory proficiency testing score for the year 2025 and interviews with the laboratory manager and technical consultant, the laboratory director is herein cited for failure to ensure that proficiency testing samples were tested as required under Subpart H of this part. The findings include: 1. Unsatisfactory proficiency testing score for General Immunology. See D2075. 2. Unsatisfactory proficiency testing score for Toxicology. See D2109. D6020 LABORATORY DIRECTOR RESPONSIBILITIES -- 3 of 4 -- 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 the surveyor's findings on October 16, 2025, lack of quality control documentation, preventive maintenance records, and instriument print-outs; the laboratory director is herein cited for the deficient practice of failure to ensure retention of documentation was followed. The findings include: 1. Missing quality control records. See D5447. 2. Missing test records. See D5789. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) (e)(12) Ensure that prior to testing patients specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results; This STANDARD is not met as evidenced by: Based on the lack of personnel competency assessment records, review of nine patient records, and interviews with the laboratory manager and technical consultant, it was determined that the laboratory director is herein cited for failure to ensure that prior to testing patient specimens, competency assessment were performed for all personnel involved in testing. See D5209. -- 4 of 4 --

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 review of the American Proficiency Institute (API) proficiency testing (PT) records, randomly chosen patient results' review, and interview with the general supervisor (GS); it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for the following Routine Chemistry analytes: Calcium ionized (Blood Gas), CO2, pH, and pCO2 for the third event of 2021 (Q3- 2021). The finding included: 1. Based on review of PT records for the Q3-2021 API reported the following unsatisfactory scores: Analyte Score Calcium 0% CO2 20% pH 20% pO2 0% 2. Based on the laboratory testing declaration submitted at the time of the survey on May 5, 2022, the laboratory analyzed and reported approximately 364,049 Routine Chemistry tests during the time the laboratory had unsatisfactory proficiency testing results. 3. The GS affirmed on 05/05/202 2at approximately 11:15 a.m. that the laboratory received the above unsatisfactory proficiency testing scores. D2098 ENDOCRINOLOGY CFR(s): 493.843(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 American Proficiency Institute (API) proficiency testing (PT) records, random patient sampling test results, and interview with the general 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 -- supervisor (GS) and laboratory testing personnel (TP); it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Parathyroid Hormone analyte PT for the Second Event of 2021 (Q2-2021). The findings included: 1. Analyte Event Performance PTH Q2-2021 50% 2. For one (1) out of seven (7) random patient sampling test results reviewed covering period from 10 /11/2021 to 2/17/2022, the laboratory analyzed and reported approximately 2,160 PTH test results during the period the laboratory received the unsatisfactory proficiency testing score. 3. The GS and TP confirmed on May 5, 2022, at approximately 11:15 a.m. that the laboratory received the above unsatisfactory proficiency testing scores for PTH. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on the surveyor's observation during the laboratory tour, lack of calibration records, and interview with the laboratory's testing personnel (TP); it was determined that the laboratory failed to perform annually the calibration of the microscope's ocular lenses according to the criteria verified or established by the laboratory as specified in 493.1253(b)(3)- when identifying ova and parasites. The findings included: 1. The laboratory performs identification of ova and parasites test procedures by light microscopy (Olympus Microscope). 2. The laboratory did not have available the calibration record of the microscope's oculars, procedure, or documentation of performing calibration of the oculars when identifying ova and parasites. 3. The TP affirmed on May 5, 2022, at approximately 12:00 p.m., that calibration of the microscope's ocular have not taken place annually. 5. According to the testing volume declaration at the time of the survey, the laboratory performed 30 parasitology samples annually. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of patient test records, laboratory's policy and procedure manual, and interview with the general supervisor (GS) and testing personnel (TP); it was determined that the laboratory failed to establish written policies and procedures for -- 2 of 3 -- an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the post analytic systems. The findings included: 1. The laboratory did not have a written policy or procedure of turnaround time (TAT) established for all the tests performed in the laboratory. 2. Based on the laboratory's annual test declaration submitted at the time of the survey on May 5, 2022; the laboratory analyzed and reported 407,422 test results for which there was no TAT established policy to monitor timely test results reporting during the postanalytic phase of testing. 3. The GS and TP affirmed on May 5, 2022, at approximately 11:30 a.m. that the laboratory did not have a written policy or procedure for monitoring TAT for each test performed in the laboratory. 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 review of the laboratory's proficiency testing, lack of calibration and documentation for the microscope oculars, lack of establishment of tests' turnaround time, and interview with the laboratory's general supervisor and testing personnel on May 5, 2022; it was determined that the laboratory director failed to ensure that several aspects of the preanalytic, analytic, and postanalytic phases of laboratory testing were monitored. See D2087, D2098, D5437, and D5891. -- 3 of 3 --

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 Surveyor review of laboratory's policy & procedure, and proficiency testing (PT) records, and interview with the laboratory technical supervisor on July 21, 2021 at 12:30 pm, the laboratory failed to successfully participate in the proficiency testing program for the compatibility test. The findings include: 1. The laboratory participated in the American Proficiency Institute (API) PT testing program for the compatibility test at the 3rd event in 2020 and 1st event in 2021. However, it received an unsatisfactory score of 80 and 60 at the 3rd and 1st events, correspondingly, resulted in an unsuccessful PT participation. Therefore, the accuracy of the patients' blood cross match test results rendered by the laboratory during that time period can 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 -- not be assured. 2. The laboratory technical supervisor on July 21, 2021 at 12:30 pm, affirmed that the laboratory did not receive a satisfactory score for the compatibility test at the 3rd event in 2020 and 1st event in 2021. 3. The laboratory's testing declaration form, signed by the laboratory director on 7/19/2021, stated that the laboratory performs approximately 150 compatibility tests, annually. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for 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 Surveyor review of laboratory's policy & procedure, and proficiency testing (PT) records, and interview with the laboratory technical supervisor on July 21, 2021 at 12:30 pm, the laboratory failed to achieve satisfactory performance for the compatibility (cross match) in two consecutive testing events. The findings include: 1. The laboratory participated in the American Proficiency Institute (API) PT testing program for the compatibility test at the 3rd event in 2020 and 1st event in 2021. However, it received an unsatisfactory score of 80 and 60 at the 3rd and 1st events, correspondingly, resulted in an unsuccessful PT performance. Therefore, the accuracy of the patients' blood cross match test results rendered by the laboratory during that time period can not be assured. 2. The laboratory technical supervisor on July 21, 2021 at 12:30 pm, affirmed that the laboratory did not receive a satisfactory score for the compatibility test at the 3rd event in 2020 and 1st event in 2021. 3. The laboratory's testing declaration form, signed by the laboratory director on 7/19/2021, stated that the laboratory performs approximately 150 compatibility tests, annually. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on Surveyor review of laboratory's policy & procedure, random patient sample, quality control (QC) and proficiency testing records, and interview with the laboratory technical supervisor during an onsite survey of the laboratory on July 21, 2021, and the severity of deficiencies found and cited herein, it was determined that the laboratory director failed to provide effective direction over the operation of the laboratory, hence the Condition: Laboratories performing high complexity testing; laboratory director was not met. The laboratory director's failure to provide direction over the laboratory operation has a consequence of potential erroneous test result reporting and patient harm. The findings include: 1. The laboratory director failed to ensure compliance with the applicable regulations. (See D6079) 2. The laboratory director failed to ensure that the testing system used for the compatibility test provided quality laboratory services in the analytical phase of testing. (See D6082) 3. The laboratory director failed to ensure that PT samples were tested as required under Subpart H of this Part. (See D6089) -- 2 of 4 -- 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 Surveyor review of laboratory's policy & procedure, random patient sample, quality control (QC) and proficiency testing records, and interview with the laboratory technical supervisor on July 21, 2021 at 12:30 pm, the laboratory director failed to assure laboratory's compliance with the applicable regulations. The findings include: See D2016 and D2181. 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 Surveyor review of laboratory's policy and procedure, and proficiency testing records, and interview with the laboratory technical supervisor on July 21, 2021 at 12:30 pm, the laboratory director failed to ensure that the testing system used for the compatibility test provided quality laboratory services in the analytical phase of testing. The findings include: See D2181. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy & procedure, and proficiency testing (PT) records, and interview with the laboratory technical supervisor on July 21, 2021 at 12:30 pm, it was determined that the laboratory director, high complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings include: For the compatibility test, the laboratory repeatedly failed to -- 3 of 4 -- 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 D2096). -- 4 of 4 --

Summary Statement of Deficiencies D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the first quarter (Q1-2017), second quarter (Q2-2017) of the American Proficiency Institute (API) proficiency testing records, random patient sampling test results, and interview with the technical supervisor, it was determined that the laboratory failed to attain an overall testing event score of at least 80 percent is unsatisfactory performance. The findings included: a. API reported the following unsatisfactory proficiency testing scores: Analyte: Score: Event/Year: Wound Aerobic 50% Q1/2017 Eye/Ear Culture 0% Q2-2017 b. For eight (8) out of eight (8) random patient sampling test results reviewed covering period from 2/25/2017 to 7/24/2017, the laboratory analyzed and reported eye, ear, wound culture and sensitivity during the approximate period that the laboratory received an unsatisfactory proficiency testing scores. c. The technical supervisor confirmed (11/27/2018, 1600), that the laboratory received the above unsatisfactory proficiency test scores. 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 review of the second quarter (Q2-2018) of the American Proficiency Institute (API) proficiency testing records, random patient sampling test results, and 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 -- interview with the technical consultant, it was determined that the laboratory failed to 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. The findings included: a. Q2-2018, API reported 60% for Iron, Total analyte. b. For four (4) out of four (4) random patient sampling test results reviewed covering period from 5/25 /2018 to 6/4/2018, the laboratory analyzed and reported Iron, Total analyte during the time the laboratory received an unsatisfactory proficiency testing score. c. The technical consultant confirmed (11/27/2018, 1600), that the laboratory received the above unsatisfactory proficiency test score. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the first quarter (Q1-2017) of the American Proficiency Institute (API) proficiency testing records, random patient sampling test results, and interview with the technical supervisor, it was determined that the laboratory failed to at least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. The findings included: a. Q1- 2017 API reported 50% for Direct Antiglobulin Antibody Test (DAT) IgG analyte. b. For two (2) out of two (2) random patient sampling test results reviewed covering period from 6/4/2018 to 11/29/2018, the laboratory analyzed and reported DAT test during the approximate time the laboratory received an unsatisfactory proficiency testing score. c. The technical supervisor confirmed (11/27/2018, 1600), that the laboratory received the above unsatisfactory proficiency test score. 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 request, direct observation for the 0.5 McFarland Solution Lot #: 12171, expiration date" 12/11/13, Cat #: ML05, interview with the testing personnel, and review of the laboratory's policy and procedure, it was determined that the laboratory failed to ensure that the laboratory must not use reagents when they have exceeded their expiration date, have deteriorated, or are of substandard quality. The findings included: a. On the day of the survey (11/27/2018), the surveyor directly observed that the 0.5 McFarland solution has expired since 2013. b. For eight (8) out of eight (8) random patient sampling test results reviewed covering period from 2/25/2017 to 7/24 /2017, the laboratory analyzed and reported eye, ear, wound culture and sensitivity. c. The testing personnel confirmed (11/27/2018, 1600), that the laboratory has been using an expired 0.5 McFarland standard for almost 5 years. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) -- 2 of 4 -- (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on request and the lack of documentation for Wright Stain, stain reactivity performance, random patient sampling test results reviewed, and interview with the technical supervisor, it was determined that the laboratory failed to each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. The laboratory must document all control procedures performed. The findings included: a. The laboratory has no documentation to show that Wright Stain, staining criteria has been met. b. For nine (9) out of nine (9) random patient sampling test results reviewed covering period from 11/12/2016 to 5/30/2018, the laboratory analyzed and reported approximately 124,000 Complete Blood Count (CBC) tests with manual differential count. c. The technical supervisor confirmed (11/27/2018, 1600) that there was no stain reactivity performance and documentation. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on request, review of the laboratory's Disk Diffusion, and the (Epsiloemeter Test (E-Test) Policies and Procedures and interview with the testing personnel, the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. The findings included: a. On the day of the survey (11 /27/2018), based on direct observation of the 0.5 McFarland turbidity standards, lot #: 12171, Exp date: 12/11/13, Cat #: ML05, the laboratory has been using an expired 0.5 McFarland standard for almost 5 years. . The Laboratory's Disk Diffusion Policy and Procedure stated: "Select 4-5 isolated colonies of the same morphological type and inoculate into sterile water so that the turbidity is that of the 0.5 McFarland standards." The E-Test policy and procedure stated: "Inoculation Preparation, Compare turbidity to that in the 0.5 McFarland standards. Adjust turbidity of inoculum to match that standard." Note: 0.5 McFarland standards are essential in the turbidity preparation of an inoculum for the sensitivity test on both Mueller Hinton and E-Test procedures. b. For eight (8) out of eight (8) random patient sampling test results reviewed covering period from 2/25/2017 to 7/24/2017, the laboratory analyzed and reported eye, ear, wound culture and sensitivity. c. The technical supervisor, testing personnel confirmed (11/27/2018, 1600) that the laboratory did not follow the Disk Diffusion and the E-Test Policies and using an expired 0.5 McFarland standard for 5 years. -- 3 of 4 -- D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on request, review of the laboratory's Critical Value Reporting Policy and Procedure and interview with the technical supervisor, the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. The findings included: a. The laboratory Critical Value Reporting Policy stated: "Read Back can be documented in the appropriate box or written in comments." b. For three (3) out of three (3) random patient sampling test results reviewed covering period from 11/26/2018 to 11/27/2018, three critical calls indicated "N" on the read back box. c. The technical supervisor, confirmed (11/27/2018, 1600) that the laboratory did not follow the Critical Value Reporting Policy and Procedure. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, procedures for Critical Value reporting, Disk Diffusion test, and the E-Test, and interview with the technical supervisor and testing personnel, it was determined that the laboratory director failed to ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. See D 5791 and D 5891. -- 4 of 4 --