San Bernardino County Pub Hth Lab

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on the lack of laboratory written policies and procedures for KOH and interviews with the laboratory director (LD), technical supervisor (TS), and testing personnel (TP); it was determined that the laboratory failed to have available and follow written procedures for KOH-mycology testing. The findings included: 1. On the day of the survey on February 6, 2024, at approximately 3:30 p.m., the laboratory failed to provide written policies and procedures for KOH-mycology testing. 2. For one (1) out of five (5) randomly selected patient test results for microbiology tests performed in the lab, no KOH standard operating procedure (SOP) was available at the time of survey. 3. The LD and TS confirmed on 02/06/2024 at approximately 3:30 p.m. that the laboratory did not have written policies and procedures available for performance of KOH mycology testing. 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. 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 the surveyors' observation during the laboratory tour and interview with the laboratory director (LD) and technical supervisor (TS), the laboratory failed to label reagents and stains throughout the laboratory. The findings included: 1. Based on the surveyor's observation during the laboratory's tour on February 6, 2024, at approximately 3:00 p.m..; no opening, preparation, or expiration date labels were used or documented for the reagents and stains (ex: water, alcohol, gram and TB stains). 2. The LD and TS affirmed in an interview conducted 2/06/2024, at approximately 3:30 p.m. that the reagents 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 31,801 test samples. 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 the surveyors' observation, examination of laboratory reagents and interview with the laboratory director (LD), technical supervisor (TS) and testing personnel (TP); it was determined that the laboratory failed to not store and use reagents when they have exceeded their expiration date. The findings included: 1. On the day of inspection, February 6, 2024, at approximately 3:00 p.m. the surveyors found while touring the laboratory sections the following reagent used beyond its expiration date: immersion oil, Cavicide, DI water, and ethanol. 2. The LD, TS, and TP affirmed on February 6, 2024, at approximately 3:15 p.m. storing throughout the laboratory the reagents listed on statement 1 is beyond its expiration date. 3. Based on the laboratory's submitted testing declaration volume signed and dated by the LD, the laboratory tests and reports approximately 31,801 test samples annually. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on the laboratory's policies and procedures, lack of documentation, and interview with the laboratory director (LD), technical supervisor (TS) and testing personnel (TP), it was determined that the laboratory failed to perform and document preventive maintenance and calibration for the timers as defined by the manufacturer and with at least the frequency specified by the manufacturer for the laboratory equipment. The findings included: 1. The laboratory's policies and procedures indicated that annual maintenance and calibration according to manufacturer's requirements be performed on all equipment used in the laboratory (ex: timers). 2. The LD, TS and TP confirmed on February 6, 2024, at approximately 3:00 p.m. that -- 2 of 4 -- the laboratory failed to follow policies and procedures for maintenance and calibration of the timers used in throughout the laboratory, indicated by the lack of preventive maintenance documentation. 3. According to the annual test volume declared by the laboratory LD, the laboratory performs approximately 31,801 tests annually. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the surveyors' review of the laboratory quality control (QC) records, randomly chosen patients' test results, lack of QC documentation, and interviews with the laboratory director (LD), technical supervisor (TS) and testing personnel (TP); it was determined that the laboratory failed to establish and perform quality control procedures that monitor the accuracy and precision of the complete analytic process including the number, the type, and the correction and documentation of those QC performed for KOH mycology testing. The findings included: 1. On the day of the survey last February 6, 2024, at approximately 3:30 p.m., the surveyors observed that QC was not performed for KOH tests. In addition, patient samples were examined, and results were reported despite the lack of QC performed. 2. The LD, TS, and TP confirmed on February 6, 2024, that the laboratory lacked an established policy and procedure for KOH QC. 3. According to the annual test volume declared and signed by the laboratory LD on February 6, 2024, the laboratory performs approximately 100 mycology tests annually including KOH preparation. D6007 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(1) 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)(1) 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 surveyors' observation, review of laboratory records, lack of standard operating procedures, quality control documentation, preventive maintenance, labelling and expiration date of reagents and interviews with the laboratory staff; it -- 3 of 4 -- was determined that the laboratory director failed to be responsible for the overall operation, including, but are not limited to 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 and analytic phases of testing. The findings included: See D5401, D5415, D5417, D5429, and D5441. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on the lack of written procedures and records for positive and negative quality control each day of KOH testing, the technical supervisor is herein cited for deficient practice in their responsibility to always provide scientific oversight and establish quality control programs in accordance with State and CLIA requirements. See D5441. -- 4 of 4 --

Summary Statement of Deficiencies D2047 PARASITOLOGY CFR(s): 493.829(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 WSLH proficiency testing records and interview with the laboratory director (LD) for the second event of 2021 (Q2-20221); it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Parasitology identification of parasites. The findings included: 1. WSLH reported an unsatisfactory score of 60 % for the identification of parasitology parasites. 2. The LD affirmed on March 3, 2022 at approximately 11:00 a.m. that the laboratory received the above unsatisfactory proficiency testing score. 3. Based on the laboratory's annual declaration the laboratory analyzed and reported one (1) parasitology test result for which the result cannot be assured. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on the laboratory's procedure manual, lack of documentation, and interview with the laboratory director (LD); it was determined that the laboratory failed to perform and document maintenance and calibration as defined by the manufacturer and with at least the frequency specified by the manufacturer for the laboratory's non- 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 -- digital thermometers. The findings included: 1. The laboratory's standard operating procedure (SOP) indicates that annual maintenance and calibration by a contracted equipment service according to manufacturer's requirements be performed on small equipment including non-digital thermometers used to verify automated digital temperature readings used for refrigerators and freezers. 2. The LD confirmed on March 3, 2022, at approximately 11:45 a.m. that the laboratory failed to follow SOP for maintenance and calibration of non-digital thermometers used in the laboratory. 3. According to the annual test volume declared by the laboratory on 2/26/2022 the laboratory performs approximately 77,287 test annually. -- 2 of 2 --

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 College of American Pathologist (CAP) laboratory proficiency testing results, Casper Report 155, nine (9) randomly selected patient records from 09 /03/2019 to 09/26/2020 and an interview with the laboratory director (LD), it was determined that the laboratory failed to attain an overall testing event score of at least 80 percent in Bacteriology which is unsatisfactory performance. The findings included: 1. The laboratory attained a score of 60% for the subspecialty of bacteriology on the analyte "Bacterial Identification" for the second PT event (Q2), 2020 for two (2) out of five (5) PT samples submitted. 2. Based on the laboratory's annual testing declaration submitted 09/18/2020, the laboratory performed and reported approximately 23,925 patient samples in microbiology which included bacteriology identification. 3. The laboratory director affirmed (09/05/2020 at 12:30 a. m.) that the laboratory received the above unsatisfactory proficiency testing score. D2038 MYCOLOGY CFR(s): 493.827(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 second quarter (Q2), 2020 of the College of the American Pathologists (CAP) proficiency testing (PT) records, Casper Report 155, nine (9) 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 -- randomly selected patient records from 09/03/2019 to 09/26/2020 and an interview with the laboratory director, it was determined that the laboratory failed to attain an overall testing event score of at least 80 percent in mycology. The findings included: 1. Q2-2020, CAP reported an unsatisfactory score of 60% for fungal identification for two (2) out of five (5) PT samples submitted. 2. Based on the laboratory's testing declaration submitted 09/18/2020, the laboratory analyzed and reported approximately 23,925 microbiology tests which included mycology. 3. The laboratory director affirmed (09/22/2020, 12:30 a. m.) that the laboratory received the unsatisfactory score of 60% in mycology. D2071 SYPHILIS SEROLOGY CFR(s): 493.835(c) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on review of the College of American Pathologists (CAP) proficiency testing (PT) results, the Casper155 report, nine (9) randomly selected patient records from 09 /03/2019 to 09/26/2020 and an interview with the laboratory director it was determined that the laboratory failed to return PT results to the proficiency testing program within the time frame specified for the Syphilis Serology subspecialty second quarter event (Q2), 2020 which resulted in an unsatisfactory performance and a score of zero (0)%. The findings included: 1. The College of American Pathologists (CAP) proficiency reported an unsatisfactory score of 0% for syphilis serology for failure to submit results within the time frame specified by the program. 2. The laboratory director affirmed 09/22/2020 at 12:30 a. m. that the Q2, 2020 CAP proficiency testing report received an unsatisfactory score of 0% for syphilis serology 3. The laboratory testing declaration submitted 09/18/2020 estimated 5,715 diagnostic immunology test resulted which included syphilis serology. -- 2 of 2 --

Summary Statement of Deficiencies D2047 PARASITOLOGY CFR(s): 493.829(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 laboratory's proficiency testing results reports, and interview with the laboratory staff, 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. The laboratory performed parasitology and enrolled its proficiency testing with CAP (College of American Pathologist) PT program to verify the accuracy of its testing performance annually. b. The laboratory attained a score of 60 % for parasitology in the 2nd 2017 PT event, which was unsatisfactory performance. c. The laboratory performed parasitology in approximately one patient sample monthly. d. The laboratory staff affirmed (01/16/2018 @12:35 pm) that the laboratory attained a score of 60 % for parasitology in the 2nd 2017 PT event, which was unsatisfactory performance. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory written policies and procedures, and interview with the laboratory staff, it was determined that the laboratory procedures and changes in procedures must be approved, signed, and dated by 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 -- before use. The findings included: a. No evidences at the time of the survey (01/16 /2018) of the written policies and procedures or changes in P & P were approved, signed, and dated by the current laboratory director before use. 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 observation of the laboratory supplies and control materials, and interview with the laboratory staff, it was determined that the laboratory failed to label thematerial currently opened and used to indicate the preparation and expiration dates. The findings included: a. The laboratory used Beckman flow cytometer, model Aquios el to report CD4, CD8 etc. b. The control materials currently used were not labeled to indicate the expiration dates. c. The laboratory staff affirmed (01/16/2018 @ 13:10 pm) that the controls were not labeled. 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 observation and interview withe laboratory staff, it was determined that the laboratory failed to discard the reagent when they have exceeded their expiration date, have deteriorated, or are of substandard quality. The findings included: a. There was a bottle of reagent labeled as Dobell O'Connor iodine for concentration method of Ova and Parasite testing. b. The expiration date for this reagent was dated 12/29/2015, then cross out and redated to 12/2016. c. The laboratory staff discarded the reagent right at my presence. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on observation and review of the laboratory's temperature charts and interview with the laboratory staff, it was determined that the laboratory failed to detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. The findings included: a. The laboratory use refrigerators and freezers to maintain and ensure the quality of any laboratory supplies, samples, and/or reagents. b. There were no temperature recorded for the dates on the weekends or holidays where no personnel come to the laboratory. c. One two-door refrigerator, Fisher Isotemp Plus, located in the area where culture media and samples kept had built in temperature monitor. d. The screen for the temperature condition showed and indicated "Pout", which translated to be "power out" at some time, yet not been noticed and investigated. e. The built-in temperature indicated 3.6 oC noted at the time of the survey (1/16/2018 @ 10:45 am) while the bottled thermometer indicated at 5 oC. f. There are two monitor systems for the temperature and showed inconsistent temperature reading. g. The laboratory failed to investigate and document all control procedures performed. D6007 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(1) 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)(1) 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 observation, review of the laboratory records, and interview with the laboratory staff, it was determined that the laboratory director failed to be responsible for the overall operation, including, but are not limited to 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. The findings included: See D-5407, D- 5415, D-5417, and D-5441 -- 3 of 3 --