Hope Health Center

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 the surveyor's review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records, five (5) random patients sampling, and interview with the technical consultant (TC); it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Hematology on the third event of 2022 (Q3-2022). The findings included: 1. The API proficiency program gave an overall unsatisfactory score of 0% for Hematology for Q3-2022. 2. The TC confirmed on January 9, 2024, at approximately 11:30 a.m. that the laboratory received the above proficiency score of 0% for Hematology as described in 1. 3. Based on the laboratory's annual testing declaration submitted on the day of the survey January 9, 2024; the laboratory analyzed and reported approximately 1,3000 Hematology samples (quarterly) during the time the laboratory had unsatisfactory proficiency testing results. 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 lack of competency assessment documentation and interview with the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- technical consultant (TC) on the day of the survey, January 9, 2024, as specified in the personnel requirements in subpart M, it was determined that the laboratory failed to establish and follow written policies and procedures to assess the TC and TP competency for the years 2022 and 2023. Findings include: 1. The laboratory fail to provide documentation of competency assessment for the TC and TP performing sample processing, testing, and reporting at the laboratory for the years 2022 and 2023. 2. This deficient practice stated in 1 was affirmed by interview with the TC on 1 /9/2024, at approximately 2:15 p.m. 3. The laboratory reported to process and report 4,000 hematology tests annually. 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 test procedure, review of five (5) randomly chosen patients results, and interview with the laboratory's technical consultant (TC) and testing personnel (TP); it was determined that the laboratory failed to have current written procedures for hematology tests performed in the laboratory. The findings included: 1. On the day of the survey on January 9, 2024, at approximately 1:30 p.m. the laboratory failed to provide the current written procedure approved and dated by the laboratory director for hematology tests performed in the laboratory. 2. For five (5) out of five (5) randomly chosen patient's hematology test results reviewed covering period from 5/17/2022 to 1/3/2024 no current written tests procedure was available to reflect a procedure followed by the TP for the hematology tests performed and reported. 3. The TC and TP confirmed on January 9, 2024, at approximately 1:00 p.m. that the laboratory did not have current written procedures available for hematology tests performed in the laboratory. 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 during the laboratory tour of quality control (QC) reagents used for hematology and interview with the laboratory's TC and TP; it was determined that the laboratory failed to label QC reagents to indicate date of use and expiration date when such reagents are used in the laboratory. The findings included: 1. Based on the surveyor's observation during the laboratory's tour on January 9, 2024, at 1:30 pm.; no opening, preparation, or expiration date labels were used or documented for the QC reagents used on the daily basis. 2. The laboratory's TC affirmed in an interview conducted 1/09/2024, at approximately 2:15 p.m. that the reagents mentioned in -- 2 of 5 -- 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 4,000 hematology test samples. 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's technical consultant (TC), it was determined that the laboratory failed to perform and document preventive maintenance and calibration of the thermometer 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 and temperature logs indicated that annual maintenance and calibration according to manufacturer's requirements be performed on the thermometers used in the laboratory. 2. The TC confirmed on January 9, 2024, at approximately 1:00 p.m. that the laboratory failed to follow policies and procedures for maintenance and calibration of the thermometer used in the laboratory S/N 12220568 Expired 4/23/2014, indicated by the lack of preventive maintenance documentation. 3. According to the annual test volume declared by the laboratory LD, the laboratory performs approximately 4,000 hematology 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 surveyor's review of the laboratory quality control (QC) records, randomly chosen patients' hematology tests results, lack of QC failure documentation policy and procedure, and interview with the technical consultant (TC) and testing personnel (TP); it was determined that the laboratory failed to establish quality control failure 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 failures when performing hematology examinations. 1. On the day of the survey January 9, 2024, at approximately 2:00 p.m., the surveyor observed that QC failures were not documented on two (2) out of five (5) patients' records reviewed. In addition, -- 3 of 5 -- patients' samples were run, and results were reported despite of QC failures. 2. The TC and TP confirmed on January 9, 2024, that the laboratory lacked an established policy and procedure for QC failures and documentation of such failures were not performed. 3. 3. According to the annual test volume declared and signed by the laboratory LD on January 8, 2024, the laboratory performs approximately 4,000 hematology tests annually. 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 review of the laboratory's policies and procedures (P&P) and records, and interview with the laboratory's technical consultant (TC) and testing personnel (TP); it was determined that the laboratory failed to follow written P&P to maintain an ongoing quality assessment, and to ensure accuracy, reliability, and timely of the patient test results reports. The findings included: 1. The laboratory failed to follow its written quality assessment P&P. 2. On the day of the survey (1/9/2024) the TC and TP failed to have any documentation of an ongoing mechanism to monitor, assess, and ensure accuracy, reliability and timely of the patient test result reports for the years 2022 and 2023. 3. The TC and TP confirmed by interview on 1/9/2024, at approximately 2:00 p.m. pm that the laboratory failed to follow its policies and procedures to maintain an ongoing quality assessment program. 4. Based on laboratory records the laboratory performed and reported approximately 4,000 diagnostic hematology tests annually. 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 technical consultant and laboratory testing personnel; 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 D2121, D5209, D5401, D5415, D5429, D5441 and D5791. -- 4 of 5 -- D6044 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(6) (b) The technical consultant is responsible for-- (b)(6) Ensuring that patient test results are not reported until all

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's patients', quality control, proficiency testing and analytic system records, and interview with the laboratory technical consultant on December 8, 2021 at 3:00 pm, the laboratory failed to retain its test analytic system records. The findings include: 1. The laboratory used an automated ABX Micros 60 instrument to do CBC test in 2019. During that year the instrument broke down and then the laboratory used a Cell Dyn CD1800 instrument to test patient sample. However, the laboratory did not document and retain any records of the test analytic system. 2. The laboratory technical consultant on December 8, 2021 at 3:00 pm, affirmed that the laboratory did not save the test system analytic records. 3. The laboratory's testing declaration form, signed by the laboratory Director on 12/6/2021, stated that the laboratory performs approximately 6,000 tests, annually. D3033 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(i) In addition, the laboratory must retain records of test system performance specifications that the laboratory establishes or verifies under 493.1253 for the period of time the laboratory uses the test system but no less than 2 years. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's documents, lack of test verification records 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 -- and interview with the laboratory technical consultant on December 8, 2021 at 2:50 pm, the laboratory failed to retain its complete blood count (CBC) test verification records for ABX Micros 60 instrument. The findings include: 1. The laboratory used the ABX Micros 60 and Cell Dyn CD1800 instruments to do CBC test in 2019. However, it failed to retain the test verification records for both instruments. Therefore, it can not be assured that the verification was performed, and the reported CBC test results were accurate, and thus may have caused patient harm. a) The laboratory used an automated ABX Micros 60 instrument to do CBC test in 2019. During that year the instrument broke down and then the laboratory used a Cell Dyn CD1800 instrument to test patient sample. Patient # 1 was found tested on 10/7/2019 on CD1800. The laboratory did not have CBC test verification records on CD1800. b) After it received the repaired ABX Micros 60 instrument, the laboratory verified the accuracy of its CBC test on the instrument, however it failed to keep the verification records. 2. The laboratory technical consultant on December 8, 2021 at 2:50 pm, affirmed that the laboratory did not save the CBC test verification results. 3. The laboratory's testing declaration form, signed by the laboratory Director on 12/6/2021, stated that the laboratory performs approximately 6,000 tests, annually. 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 Surveyor review of laboratory's documents, test reports, lack of test verification and analytic system records and interview with the laboratory technical consultant on December 8, 2021 at 3:00 pm, the laboratory director failed to ensure compliance with the applicable regulations. The findings include: See D3031 and D3033. -- 2 of 2 --