Laboratorio Clinico Camuy

Summary Statement of Deficiencies D5014 GENERAL IMMUNOLOGY CFR(s): 493.1208 If the laboratory provides services in the subspecialty of General immunology, 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 Mycoplasma pneumoniae quality control records patient records review ( 2021-2022 ) and interview with the laboratory supervisor, it was determined that the laboratory failed to meet the requirements in the subspecialty of General Immunology. The findings include: 1. The Mycoplasma pneumoniae quality control records showed that laboratory did not include an external positive and a negative control material each day of patient testing. Refer to D5449 2. The laboratory general supervisor confirmed on March 3, 2022 at 12:00 P.M, that the laboratory failed to include each day of testing a negative and positive control material when performed Mycoplasma pneumonia test. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program ( PRPTP ) records review ( 2020- 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 -- 2021) and laboratory general supervisor interview , it was determined that the laboratory failed to verify the accuracy of the hematology specialty when the PRPTP did not have hematology samples in the second testing event performed in June 2021. The findings include: 1. Puerto Rico Proficiency testing records were reviewed from February 2020 to December 2021. 2. In the Hematology second testing event , the PRPTP informed the laboratory that they were not able to ship the scheduled hematology samples. The letter included instructions about, how to verify the accuracy of the missed shipment. 3. The laboratory proficiency testing records showed on March 3, 2022 at 9:35 A.M., that the laboratory did not verify the accuracy of the hematology specialty tests in the second testing event of year 2021. 4. The general supervisor stated on March 3, 2022 at 9:40 A.M., that the laboratory did not verify the accuracy of the hematology tests. 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. This STANDARD is not met as evidenced by: Based on General Immunology (Mycoplasma pneumoniae test) quality control records review (years 2021-2022) and laboratory general supervisor interview, it was determined that the laboratory did not include an external positive and negative control material each day of Mycoplasma pneumoniae patient testing. The findings include: 1. General Immunology (Mycoplasma pneumoniae test) quality control records were review on March 3, 2022 at 11:50 A.M., from March 30, 2021 to March 3, 2022. 2. Review of Mycoplasma pneumoniae quality control and patient results record showed that the laboratory did not include any control material each day of patient testing since March 30, 2021. 3. The laboratory general supervisor confirmed on March 3, 2022 at 12:00 P.M, that the laboratory failed to include a negative and positive control material each day of testing when performed Mycoplasma pneumonia test. 4. The laboratory did not include any control material, when 281 out 281 patient specimen were processed and since March 30, 2021. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on syphilis serology quality control records review (years 2021-2022 ) and laboratory general supervisor interview, it was determined that the laboratory did not -- 2 of 4 -- evaluate the new lot of Rapid Plasma reagin (RPR) test for positive and negative reactivity prior to placed it in routine use. The findings include: 1. The laboratory syphilis serology quality control records were review on March 3, 2022 at 11:40 A.M. from January 2021 to March 2022. 2. The laboratory received the following reagent kit for RPR Method and no evaluation of their reactivity was performed when began to use on June 1, 2021: Test Lot Expiration Date RPR 0421275 1/31/23 3. The laboratory processed and reported forty six ( 46 ) RPR (Rapid plasma reagin) patient's samples from June 1, 2021 to February 23, 2022. 4. The laboratory general supervisor confirmed on March 3, 2022 at 11:50 A.M. that the laboratory did not evaluate the new lot of Rapid Plasma reagin (RPR) test for positive and negative reactivity prior to placed it in routine use. D6056 CLINICAL CONSULTANT CFR(s): 493.1415 The laboratory must have a clinical consultant who meets the qualification requirements of 493.1417 of this part and provides clinical consultation in accordance with 493.1419 of this part. This CONDITION is not met as evidenced by: Based on personnel records review ( 2021 ) and laboratory general supervisor interview , it was determined that the laboratory clinical consultant position is not filled since February 16, 2022. The finding includes: 1. The laboratory general supervisor confirmed on March 3, 2022 at 8:55 A.M., that the previous laboratory clinical consultant resigned on February 16, 2022 and that laboratory position was not filled. 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: 1. Based on Mycoplasma pneumonia and syphilis serology quality control records ( 2021-2022 ) and interview with the laboratory general supervisor, it was determined that the laboratory director failed to ensure compliance with the requirements for analytic systems. Refer to D6093. 2. Based on laboratory general supervisor interview on March 3, 2022 , it was determined that the laboratory director failed to hire a new clinical consultant . Refer to D 6101. 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: -- 3 of 4 -- Based on Mycoplasma pneumonia and syphilis serology quality control records ( 2021-2022 ) and interview with the laboratory general supervisor, it was determined that the laboratory director failed to ensure compliance with the requirements for analytic systems. Refer to D5449 and D5471. D6101 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(11) The laboratory director must employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart. This STANDARD is not met as evidenced by: Based on interview with the laboratory general supervisor on March 3, 2022 , it was found that the laboratory director did not hire a clinical consultant since February 16, 2022. The findings include: 1. The laboratory director did not fill the clinical consultant position. 2. The laboratory general supervisor confirmed on March 3, 2022 at 8:55 A.M., that the laboratory did not fill the clinical consultant position since February 16, 2022. -- 4 of 4 --

Summary Statement of Deficiencies 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 review in 2017-2018 and laboratory director interview at 10:45 AM on March 16, 2018, it was determined that the laboratory failed to perform syphilis serology test as required by manufacturer's instructions by Immunostics and Aim RPR method. The findings include: 1. The manufacturer's establishes that the RPR (Rapid plasma reagin) test must be performed at room temperature between 20 C to 30 C . 2. Syphilis serology records were reviewed from January 2017 to March 15, 2018, the records showed that the laboratory room temperature was below 20 C during the following months: August 2017- 9 of 21 days ( 66 RPR patients ) December 2017 -5 of 15 days ( 15 RPR patient samples ) January 2018- 8 of 17 days ( 16 RPR patient samples ) February 2018- 13 of 17 days ( 72 RPR patient samples ) March 2018 - 4 of 9 days ( 9 RPR patient samples ) 3. The laboratory processed and reported 177 RPR patient samples during those months. 4. The laboratory general supervisor confirmed that the laboratory performed RPR (Rapid plasma reagin) tests below the range established by the manufacturer's . 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 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 -- deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on hematology quality control records review and laboratory general supervisor interview at 11:15 a.m. on March 16, 2018, it was determined that the laboratory used the CBC (complete blood count) controls materials that have exceeded their expiration date. The findings include: 1. The laboratory analyzed and reported CBC (complete blood count) patient's specimens by the Sysmex 800 i system. 2. The laboratory used Sysmex 800i control material lot 6290804, exp. date : 1/5/17 to perform CBC from 1/15/17 to 1/24/17. 3. The laboratory used Sysmex 800i control material lot 635500804, exp. date : 3/12/17 to perform CBC from 3/12/17 to 3/27/17. 4. The laboratory processed and reported 170 patient samples those days for CBC test. 5. The laboratory general supervisor confirmed on March 16, 2018 at 11:15 A.M. that the laboratory used hematology control material that exceed their expiration date. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on routine chemistry calibration verification records review and laboratory general supervisor interview at 11:45 a.m. on March 16, 2018, it was determined that the laboratory failed to perform at least every 6 months the calibration verification procedures for the routine chemistry (Lytes) tests processed by the Dimension system. The findings include: 1. The laboratory uses a Dimension system for routine chemistry tests. 2. From March 2016 to March 2018, the routine chemistry calibration verification records showed that the laboratory did not perform at least every 6 months the calibration verification procedures for the routine chemistry (Lytes) tests processed by Dimension system. 3. The laboratory general supervisor confirmed on March 16, 2018 at 11:45 A.M. that the last calibration verification for electrolytes tests was performed on November 2016. -- 2 of 4 -- 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 quality assessment (QA) records review in 2016/2018 and laboratory general supervisor interview on March 16, 2018 at 11:30 AM, it was determined that the laboratory failed to follow the established Quality Assessment Program to monitor and evaluate the requirement for analytic systems. The findings include: 1. The laboratory failed to perform syphilis serology test as required by manufacturer's instructions by Immunostics and Aim RPR method. Refer to D5411. 2. The laboratory used the CBC (complete blood count) controls materials that have exceeded their expiration date. Refer to D5417. 3. The laboratory failed to perform at least every 6 months the calibration verification procedures for the routine chemistry (Lytes) tests processed by the Dimension system. Refer to D5439. 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 hematology , syphilis serology and routine chemistry quality control records review and interview with the laboratory general supervisor on March 16, 2018 at 11: 30 A.M. , it was found that the laboratory director did not fulfill his responsibilities. The findings include: 1. The laboratory failed to perform syphilis serology test as required by manufacturer's instructions by Immunostics and Aim RPR method. Refer to D5411. 2. The laboratory used the CBC (complete blood count) controls materials that have exceeded their expiration date. Refer to D5417. 3. The laboratory failed to perform at least every 6 months the calibration verification procedures for the routine chemistry (Lytes) tests processed by the Dimension system. Refer to D5439. 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. This STANDARD is not met as evidenced by: Based on Quality Assessment (QA) records review and laboratory general supervisor interview at 11:45 a.m. on March 16, 2018 , it was determined that laboratory failed to ensure compliance with quality assessment (QA) requirements. Refer to D5791. -- 3 of 4 -- 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 hematology, syphilis serology and routine chemistry quality control records review ( 2016-2018) and laboratory general supervisor interview on March 16, 2018 at 11:50 AM, it was determined that the general supervisor failed to follow quality control procedures. The finding includes: 1. The laboratory general supervisor did not evaluate aspects regarding: control procedures. Refer to D5411, D5417 and D5439. -- 4 of 4 --