Laboratorio Clinico Alhambra

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA recertification survey at LABORATORIO CLINICO ALHAMBRA on July 10, 2024. The laboratory was surveyed under 42 CFR part 493 CLIA requirements. The following condition level deficiencies were found during the unannounced routine CLIA recertification survey ending on July 10, 2024. D5012 SYPHILIS SEROLOGY CFR(s): 493.1207 If the laboratory provides services in the subspecialty of Syphilis serology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on manufacturer's instructions, syphilis serology quality control records, patient's reports worksheets review (years 2023-2024) and laboratory general supervisor interview on July 10, 2024 at 10:35AM, it was determined that the laboratory failed to ensure compliance with the analytic system requirements for syphillis serology tests. Refer to D 5405 and D5411. D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Based on manufacturer's instructions, syphilis serology quality control records, patient's reports worksheets review (years 2023-2024) and laboratory general supervisor interview on July 10, 2024 at 10:35AM, it was determined that the laboratory failed to follow the manufacturer's instructions when reported and performed 142 out of 820 syphilis serology patient's samples by Aim Rapid plasma reagin (RPR) method in 31 out of 132 days since January 2, 2024. The findings include: 1. The laboratory uses Aim Rapid plasma reagin (RPR) method when patient's specimen were tested for syphilis serology since January 2024. Reviewed on July 10, 2024 at 10:35AM. 2. The manufacturer's instructions establishes that three levels of control material (non-reactive, minimal to moderate and reactive) must be included each day of testing. Reviewed on July 10, 2024 at 10:40AM. 3. From January 2, 2023 to July 9, 2024 (31 days), the syphilis serology quality control records and the patient's reports worksheet showed that the laboratory did not include the three levels of control material when it processed and reported 142 out of 820 patient's specimens for syphilis serology by Aim RPR method. Reviewed on July 10, 2024 at 10:45AM. 4. The laboratory general supervisor stated on July 10, 2024 at 10:55AM that the laboratory did not include the three levels of control material when it processed and reported patients specimens for syphilis serology by Aim RPR method those days. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on manufacturer's instructions, syphilis serology quality control records, patient's reports worksheets review (years 2023-2024) and laboratory general supervisor interview on February 8, 2023 at 10:35AM, it was determined that the laboratory failed to perform syphilis serology test as required by the manufacturer's instructions when reported and performed 142 out of 820 syphilis serology patient's samples by Aim Rapid plasma reagin (RPR) method in 31 out of 132 days. The findings include: 1. The laboratory uses Aim Rapid plasma reagin (RPR) method to perform RPR (rapid plasma reagin) syphilis serology patient's samples tests. Reviewed on July 10, 2024 at 10:35AM. 2. The manufacturer requires that the laboratory must perform the needle calibration and must211 be removed after each day of testing, rinsed with distilled water, and allowed to air dry. In addition, the laboratory should be adjusted and verify the mechanical rotator at 100 5 rpm for eight (8) minutes and monitor the room temperature (20 to 30 C) in the laboratory. Reviewed on July 10, 2024 at 10:40AM. 3. From January 2, 2024 to July 9, 2024 (31 days), the syphilis serology quality control records showed that the laboratory did not did not document nor verify the needle calibration, needle clean, rotator rpm or the room temperature monitoring in the RPR (Rapid plasma reagin) testing area in the following days: Reviewed on July 10, 2024 at 10:45AM. Date #samples 1/2/2024 3 1 /4/2024 1 1/5/2024 2 1/10/2024 9 1/13/2024 3 1/15/2024 1 1/17/2024 41 1/19/2024 3 1 /23/2024 11 1/27/2024 3 2/1/2024 1 2/5/2024 2 2/7/2024 5 2/10/2024 5 2/15/2024 2 2 /23/2024 4 3/2/2024 1 3/5/2024 6 3/12/2024 1 3/16/2024 2 3/22/2024 1 3/27/2024 1 4 /5/2024 4 4/11/2024 2 4/18/2024 2 4/29/2024 9 5/7/2024 3 5/25/2024 2 6/6/2024 1 6 /26/2024 3 7/8/2024 8 4. The laboratory processed and reported one hundred forty two -- 2 of 4 -- (142) RPR (Rapid plasma reagin) patient's samples tests those days. Reviewed on July 10, 2024 at 10:45 AM. 5. The laboratory general supervisor stated on July 10, 2024 at 10:55AM, that the laboratory did not document nor verify the needle calibration, clean needle, rotator rpm nor the room temperature monitoring in the RPR (Rapid plasma reagin) testing area those days. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the urinalysis quality control records review (years 2023-2024) and laboratory general supervisor interview on July 10, 2024 at 9:45 AM, it was determined that the laboratory did not include or document a negative microscopic control material for manual microscopic urinalysis examinations, when 4,048 (in year, 2023) and 2,235 (in year 2024) patients were processed and reported from January 2, 2023 to July 9, 2024. The findings include: 1. The urinalysis quality control records were reviewed on July 10, 2024 at 9:45 AM. 2. The recoesds showed that the laboratory did not include or document a negative control material for urinalysis microscopy test. Reviewed on July 10, 2024 at 9:45 AM. 3. The laboratory director confirmed on July 10, 2024 at 10:00 AM, that no negative microscopy control was implemented from January 2, 2023 to July 9, 2024, when when 4,048 (in year,2023) and 2,235 (in year 2024) patients were processed and reported. 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 manufacturer's instructions, syphilis serology quality control records, patient's reports worksheets review (years 2023-2024) and laboratory general supervisor interview on July 10, 2024 at 10:35AM, it was determined that the laboratory director failed to fulfill his responsibilities and duties to ensure compliance with the laboratory quality control requirements. Refer to D6093. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify -- 3 of 4 -- failures in quality as they occur. This STANDARD is not met as evidenced by: Based on manufacturer's instructions, syphilis serology and urinalysis quality control records, patient's reports worksheets review (years 2023-2024) and laboratory general supervisor interview on July 10, 2024 at 10:35AM, it was determined that the director failed to ensure the compliance with the quality control program, manufacturer's instructions when reported and performed 142 out of 820 syphilis serology patient's samples by Aim Rapid plasma reagin (RPR) method in 31 out of 132 days since January 2, 2024 and did not include or document a negative microscopic control material for manual microscopic urinalysis examinations, when 4,048 (in year 2023) and 2,235 (in year 2024) patients were processed and reported from January 2, 2023 to July 9, 2024.. Refer to D5405, D5411 and D5445. D6144 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463 The general supervisor is responsible for day-to-day supervision or oversight of the laboratory operation and personnel performing testing and reporting test results. This STANDARD is not met as evidenced by: Based on manufacturer's instructions, syphilis serology quality control records, patient's reports worksheets review (years 2023-2024) and laboratory general supervisor interview on July 10, 2024 at 10:35AM, it was determined that the general supervisor did not assure that quality control procedures were followed by the testing personnel. Refer to D5405, D5411 and D5445. D6177 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(b)(3) Each individual performing high complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on manufacturer's instructions, syphilis serology quality control records, patient's reports worksheets review (years 2023-2024) and laboratory general supervisor interview on July 10, 2024 at 10:35AM, it was determined that the that testing personnel failed to follow quality control procedures, manufacturer's instructions when reported and performed 142 out of 820 syphilis serology patient's samples by Aim Rapid plasma reagin (RPR) method in 31 out of 132 days since January 2, 2024 and did not include or document a negative microscopic control material for manual microscopic urinalysis examinations, when 4,048 (in year 2023) and 2,235 (in year 2024) patients were processed and reported from January 2, 2023 to July 9, 2024.. Refer to D5405, D5411 and D5445. -- 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 review of proficiency testing records (years 2023-2024), it was determined that the laboratory failed to attain successful participation in a Proficiency Testing Program for hematology subspecialty. Refer to D2130. 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. 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 proficiency testing records (years 2023-2024), it was determined that the laboratory failed to achieve satisfactory performance in two consecutive testing events for Hematocrit (HCT) tests. The finding includes: 1. The laboratory obtained unsatisfactory results for Hematocrit (HCT) in third testing event for year 2023 (0%) and first testing event for year 2024 (0%). 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 review of proficiency testing records (years 2023-2024), it was determined that the laboratory director failed to ensure the laboratory's successful participation in a Proficiency Testing Program for hematology tests. Refer to D2130. -- 2 of 2 --

Summary Statement of Deficiencies D2127 HEMATOLOGY CFR(s): 493.851(d) 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 Puerto Rico Proficiency Testing Program records reviewed ( 2019-2020) and laboratory general supervisor interview on December 22, 2020 at 9:30 A.M., it was determined that the laboratory failed to report the hematology proficiency testing results within the time frame established by the program. The findings include: 1. Proficiency testing records were reviewed from February 2019 to November 2020. 2. The deadline of the second testing event report of hematology tests was August 2, 2019. 3. The laboratory did not report the second testing event of hematology within the time frame established by the Proficiency Testing Program and results in a score of 0 for the testing event. 4. The laboratory general supervisor confirmed on December 22, 2020 at 10:00 A.M. that the laboratory did not report the hematology proficiency testing results of the second testing event within the time frame established by the Proficiency Testing Program. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible 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 -- case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on observation of Bacteriology area and interview with the laboratory general supervisor on December 22, 2020 at 12: 00 P.M., it was determined that the laboratory failed to minimized the contamination of patient specimens in the bacteriology area. Refer to D 3001. D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on observation and laboratory general supervisor interview on December 22, 2020 at 12:00 P.M., it was determined that the laboratory failed to ensure minimized the contamination of patient specimens in the bacteriology area. The findings include: 1. The laboratory had in the area a Vitek 2 system, refrigerator for store reagent and Culture media , a computer system and a small refrigerator over a table used to store foods. 2. Another refrigerator was also observed at the area .The refrigerator contained inside ( milk, salad dressing, pancake syrup, sandwish and drinks) . Over the refrigerator observed corn flakes boxes ( 2 ) and bottle milk ( 4 ) 3. The laboratory general supervisor confirmed on December 22, 2020 the testing area were crowded and the foods refrigerator can not located in the bacteriology area and neither area when patient samples were perform. 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 observation of Bacteriology area and interview with the laboratory general supervisor on December 22, 2020 at 12: 00 P.M., it was determined that the laboratory director failed to fulfill his responsibilities and duties to ensure compliance with the laboratory standard of facilities requirements. Refer to D 3001. D6083 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) The laboratory director must ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed. This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on bacteriology area observation and interview with the laboratory general supervisor on December 22, 2020 at 12:00 P.M. , it was determined that the laboratory director did ensure that the physical plant in bacteriology area (crowded space) were appropriate for specimen testing and handling. Refer to D 3001. 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 Puerto Rico Proficiency Program testing records review ( 2019-2020 ) and laboratory general supervisor interview on December 22, 2020 at 10:00 AM, it was determined that the laboratory director failed to ensure that proficiency testing samples were tested as required under Subpart H requirements. Refer to D2127. D6144 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463 The general supervisor is responsible for day-to-day supervision or oversight of the laboratory operation and personnel performing testing and reporting test results. This STANDARD is not met as evidenced by: Based on observation of Bacteriology area and interview with the laboratory general supervisor on December 22, 2020 at 12: 00 P.M., it was determined that the laboratory general supervisor failed to ensure compliance with the laboratory standard of facilities requirements. Refer to D 3001. -- 3 of 3 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on laboratory procedures manual, laboratory quality control records review in years 2016-2018 and laboratory general supervisor interview on July 19, 2018 at 1:00 PM, it was determined that the laboratory failed to monitor and document the laboratory's relative humidity. The findings include: 1. The laboratory procedures manual establishes that the laboratory monitor and document daily the relative humidity (45-65%). 2. From August 1, 2016 to July 19, 2018, the records showed that the laboratory did not monitor and document the daily relative humidity since January 2017. 3. The laboratory general supervisor confirmed on July 19, 2018, that the laboratory did not monitor and document the relative humidity since January 2017. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. 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 -- This STANDARD is not met as evidenced by: A. Based on manufacturer's instructions, endocrinology quality control records review in years 2016-2018 and laboratory general supervisor interview on July 19, 2018 at 1: 00 PM, it was determined that the laboratory failed to include each day of testing the positive and the negative control materials when patients samples were tested for qualitative Human Chorionic Gonadotropin (HCG) by OSOM method. The findings include: 1. The laboratory uses Human Chorionic Gonadotropin (HCG) by OSOM method. 2. The manufacturer's establishes to include each day of testing one negative and one positive material control. 2. From October 2016 to July 2018, the records showed that the laboratory failed to include at least once a day, a negative nor positive control material when 2 of 2 patients specimens were processed and reported for qualitative HcG patient's samples in the following days: Date # samples 2/9/18 1 2/28 /18 1 3. The laboratory processed and reported two (2) HcG patient's samples on February 9, 2018 and February 28, 2018, respectively. 4. The laboratory general supervisor confirmed on July 19, 2018 that the laboratory failed to include each day of testing the positive and the negative control materials when patient's sample's were tested for qualitative Human Chorionic Gonadotropin (HCG) by OSOM method those days. B. Based on manufacturer's instructions, endocrinology quality control records review in years 2016-2018 and laboratory general supervisor interview on July 19, 2018 at 1:00 PM, it was determined that the laboratory failed to verify the validity of each kit when material control and HcG patients samples were tested for qualitative Human Chorionic Gonadotropin (HCG) by OSOM method. The findings include: 1. The laboratory uses Human Chorionic Gonadotropin (HCG) by OSOM method. 2. The manufacturer's establishes to verify the validity of each HcG kit, monitor and evaluate the control line does appears. (Invalid kit means that the control line does not appear). 2. From October 2016 to July 2018, the records showed that the laboratory failed to evaluate nor document the validity of each kit when HcG patients samples were processed and reported in the following days: Date # samples 2/9/18 1 2/28/18 1 3. The laboratory processed and reported two (2) HcG patient's samples on February 9, 2018 and February 28, 2018, respectively. 4. The laboratory general supervisor confirmed on July 19, 2018 that the laboratory failed to verify the validity of each kit when material control and patients samples were tested for qualitative Human Chorionic Gonadotropin (HCG) by OSOM method. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. -- 2 of 5 -- This STANDARD is not met as evidenced by: A. Based on laboratory procedure manual, routine chemistry quality control review in years 2016-2018 and laboratory general supervisor interview at 1:00 PM, it was determined that the laboratory failed to evaluate the quality control results for routine chemistry tests processed by the Vitro 250 system. The findings include: 1. The laboratory uses a Vitros 250 system to perform routine chemistry patient's samples tests for Albumin, ALP (Alkaline phosphate), ALT (Alanine Aminotransferase), AMY (Amylase), AST (Aspartate Aminotrasferase), T. Bili (Total Bilirubin), BUN (Urea Nitrogen) and Calcium. 2. The laboratory uses two material controls for each test. (verify I and verify II). 3.. The laboratory establishes to evaluate in Levy- Jenninsg graphs control results each month. 4. Review of routine chemistry quality control records from October 2016 to June 2018, showed that the laboratory performed quality control procedures, however, did not evaluate in Levy-Jennings graphs the quality control results in the following dates: Test Date Control Level Albumin 2/6/18 Verify II 3/15/18 Verify I 5/23/18 Verify II 6/1/18 Verify II ALP 2/15 /18 Verify II 3/13/18 Verify I 5/23/18 Verity II 6/8/18 Verify I 6/16/18 Verify I ALT 3 /15/18 Verify I 4/26/18 Verify II 5/9/18 Verify I AMY 3/6/18 Verify I AST 1/22/18 Verify II 3/15/18 Verify I 5/23/18 Verify II T. Bili 3/15/18 Verify I 6/11/18 Verify I 6 /12/18 Verify I Bun 3/15/18 Verify I Calcium 3/15/18 Verify I 5. The laboratory reported and processed aproximately One hundred (100) patient's samples during those days. 6. The laboratory general supervisor confirmed on July 19, 2018 that the laboratory did not evaluate in Levy-Jennings graphs the quality control results those days. B. Based on laboratory procedure manual, special chemistry quality control review in years 2016-2018 and laboratory general supervisor interview at 1:00 PM, it was determined that the laboratory failed to evaluate the quality control results for routine chemistry tests processed by the Elecsys 2010 system. The findings include: 1. The laboratory uses a Elecsys 2010 system to perform special chemistry patient's samples tests for FT4 (Free Thyroxine), TSH (Thyroid Stimulating hormone, (PSA (Prostate specific antigen, T4 (Thyroxine), Vit D (Vitamin D, 25OH) and Vit. B12 (Vitamin B12) 2. The laboratory uses three material controls for each test. (V-0, V-1, V-2). 3.. The laboratory establishes to evaluate in Levy-Jenninsg graphs control results each month. 4. Review of special chemistry quality control records from October 2016 to June 2018, showed that the laboratory performed quality control procedures, however, did not evaluate in Levy-Jennings graphs the quality control results in the following dates: Test Date Control Level TSH 1/18/18 V-2 3/27/18 V-2 4 /20/18 V-2 FT4 1/22/18 V-2 1/23/18 V-2 1/25/18 V-1 1/26/18 V-2 2/2/18 V-2 2/23/18 V-2 PSA 2/2/18 V-2 2/14/18 V-2 2/23/18 V-2 3/27/18 V-2 4/20/18 V-2 5/9/18 V-1 5 /10/18 V-2 T4 1/8/18 V-2 3/27/18 V-2 4/20/18 V-2 5/16/18 V-1 Vit D 2/22/18 V-1 3/9 /18 V-1 5/10/18 V-1, V-2 Vit B12 12/20/17 V-0 4/19/18 V-0, V-2 5/10/18 V-0, V-2 5. The laboratory reported and processed aproximately Thirty (30) patient's samples during those days. 6. The laboratory general supervisor confirmed on July 19, 2018 that the laboratory did not evaluate in Levy-Jennings graphs the quality control results those days. 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. -- 3 of 5 -- This STANDARD is not met as evidenced by: Based on quality control records review in years 2016-2017 and laboratory general supervisor interview on July 19, 2018 at 1:00 PM, it was determined that the laboratory failed to follow the established Quality Assessment Program to monitor and evaluate the requirements for analytic system. The findings include: 1. The laboratory failed to monitor and document the laboratory's room relative humidity. Refer D5413 2. The laboratory failed to include each day of testing the positive and the negative control materials when patient's specimens were tested for qualitative Human Chorionic Gonadotropin (HCG) by OSOM method. Refer D5449. 3. The laboratory failed to evaluate the quality control results for routine chemistry tests processed by the Vitro 250 system. Refer D5469. 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 quality assesment ( QA) records review in years 2016-2018 and laboratory general supervisor interview on July 19, 2018 at 1:00 PM, it was determined that the laboratory failed to monitor problems identified in the post analytical systems (turn around time) . The finding includes: 1. The laboratory Quality Assessment records schedule for turn around time evaluation showed that it must be performed every year. 2. The laboratory did not perform any evaluation to the post analytic system since January 2016. 3. The laboratory general supervisor confirmed on July 19, 2018 that the laboratory failed to monitor problems identified in the post analytical systems (turn around time) D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control 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 laboratory procedure manual, quality control records review in years 2016- 2018 and laboratory general supervisor interview at 1:00 PM on July 19, 2018, it was determined that the laboratory failed to ensure compliance with the requirements for analytic systems. Refer to D5413, D5449 and D5469. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. -- 4 of 5 -- This STANDARD is not met as evidenced by: Based on Quality Assessment records review in years 2016-2018 and laboratory general supervisor interview at 1:00 PM on July 19, 2018, it was determined that the laboratory failed to ensure compliance with quality assessment (QA) requirements. Refer to D5791 and D5891. D6144 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463 The general supervisor is responsible for day-to-day supervision or oversight of the laboratory operation and personnel performing testing and reporting test results. This STANDARD is not met as evidenced by: Based on laboratory procedure manual, quality control records review in years 2016- 2018 and laboratory general supervisor interview at 1:00 PM on July 19, 2018, it was determined that the general supervisor failed to follow quality control procedures. The findings include: 1. The laboratory failed to monitor and document the laboratory's room relative humidity. Refer D5413 2. The laboratory failed to include each day of testing the positive and the negative control materials when patient's specimens were tested for qualitative Human Chorionic Gonadotropin (HCG) by OSOM method. Refer D5449. 3. The laboratory failed to evaluate the quality control results for routine chemistry tests processed by the Vitro 250 system. Refer D5469. D6177 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(b)(3) Each individual performing high complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on laboratory procedure manual, quality control records review in years 2016- 2018 and laboratory general supervisor interview at 1:00 PM on July 19, 2018, it was determined that testing personnel failed to follow quality control procedures. The findings include: 1. The laboratory failed to monitor and document the laboratory's room relative humidity. Refer D5413 2. The laboratory failed to include each day of testing the positive and the negative control materials when patient's specimens were tested for qualitative Human Chorionic Gonadotropin (HCG) by OSOM method. Refer D5449. 3. The laboratory failed to evaluate the quality control results for routine chemistry tests processed by the Vitro 250 system. Refer D5469. -- 5 of 5 --