Laboratorio Clinico La Merced

Summary Statement of Deficiencies D0000 A Proficiency Test Desk Review offsite survey was performed on August 8, 2024 to Laboratorio Clnico La Merced, the laboratory was found out of compliance with the following conditions: 42 CFR 493.803 Proficiency Testing Succesful Participation 42 CFR 493.1441 Laboratory Director, high complexity 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 Puerto Rico Proficiency Testing scores (years 2023-2024) and CASPER Report 0155D scores, it was determined that the laboratory failed to attain successful participation in a Proficiency Testing Program for bacteriology specialties. Refer to D2028. 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 -- D2028 BACTERIOLOGY CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of Puerto Rico proficiency testing scores (years 2023-2024) and CASPER Report 0155D scores, it was determined that the laboratory failed to achieve satisfactory performance in two out two consecutive proficiency testing events for bacteriology. The finding includes: 1. The Puerto Rico Proficiency and CASPER Report 0155D ocres, showed that the laboratory obtained the following unsatisfactory scores: a. Third testing event for 2023 (65%) b. First testing event for the year 2024 (56.5%). 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 scores (years 2023-2024) and CASPER Report 0155D scores, it was determined that the laboratory director failed to ensure the laboratory's successful participation in a Proficiency Testing Program for bacterioloby tests. Refer to D6079. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on Puerto Rico proficiency testing scores (years 2023-2024) and CASPER Report 0155D scores, it was determined that the laboratory director did not ensure that the laboratory had a satisfactory participation in the bacteriology tests during the third testing event of year 2023 and first testing event of year 2024. Refer to D2028. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program ( PRPTP ) records review ( year 2021-2022 ) and laboratory general supervisor interview on August 22, 2022 , it was determined that the laboratory director and testing personnel failed to sign the attestation statements. The findings include: 1. Puerto Rico Proficiency testing records were review from February 2021 to July 2022. ( review on August 22, 2022 at 11:09 a. m. ) 2. The review of records showed that the laboratory director and laboratory general supervisor ( testing personnel ) did not sign the attestation statements of the Proficiency testing records from February 2021 to December 2021. ( review on August 22, 2022 at 11:10 a.m. ) 3. The laboratory general supervisor confirmed on August 22,2022 that the laboratory director and general supervisor ( testing personnel ) failed to sign the attestation statements in 2021. ( review on August 22, 2022 at 11: 15a.m. ) D5002 BACTERIOLOGY CFR(s): 493.1201 If the laboratory provides services in the subspecialty of Bacteriology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1261, and 493.1281 through 493.1299. This CONDITION 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 6 -- Based on bacteriology quality control records review from year 2021-2022 and interview with the laboratory director on August 22, 2022 at 2:10 p.m. it was determined that the laboratory failed to ensure compliance with the analytic system requirements of bacteriology. The findings include: 1. The laboratory failed to follow written instructions for urine culture processing.. Refer to D5407. 2. The laboratory failed to check each batch of lot of Blood Agar / Mc Conkey biplate and chocolate culture media plates for its ability to support growth. and sterility. Refer to D5477. 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: Based on syphilis serology quality control records review ( year 2021-2022 ) and laboratory general supervisor interview on August 22, 2022 , it was determined that the laboratory failed to follow the manufacturer's instruction when patient specimen were tested for syphilis serology by Rapid plasma reagin (RPR) method. The findings include: 1. The manufacturer's instruction establishes that three levels of control material ( non reactive, minimal to moderate and reactive) must be included each day of testing. ( review on August 22, 2022 at 1:45 p.m. ) 2. Syphilis serology quality control record were reviewed from January 2021 to July 2022. ( review on August 22, 2022 at 1:47 p.m. ) 3.The syphilis serology quality control records from May 16, 2022, showed that the laboratory did not include the three levels of control material when it processed and reported 2 out of 2 patients specimens for syphilis serology by RPR method (patients specimens # 13757 and # 137911 ). ( review on August 22, 2022 at 1:55 p.m.) 4. The general supervisor confirmed that the laboratory failed to performed nor documented the quality control procedures those days ( review on August 22, 2022 at 1:57 p.m. ) . 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 bacteriology procedure manual review , culture media quality control work sheet ( year 2021-2022 ) and laboratory general supervisor interview on August 22, 2022, it was determined that the laboratory failed to failed to follow written instructions for urine culture processing. The findings include : 1.The bacteriology written procedure manual review stated that the laboratory use BA and McConkey agar media single plate to perform urine culture test, however, the culture media quality control work sheet showed that the laboratory uses BA/McConkey biplate agar media to perform this culture. ( review on August 22, 2022 at 12:38 p.m. ) 2. During the survey the laboratory general supervisor stated that the laboratory reported and processed 510 urine patient culture in 2021 and 227 urine culture in 2022. ( review on August 22, 2022 at 12:42 p.m. ) 3. During the survey on August 22, 2022 at 12:40 p.m -- 2 of 6 -- the bacteriology culture media QC worksheet was reviewed. The document showed that the urine samples were inoculated in a BA/ Mc biplate , instead of single plates. 4. The laboratory general supervisor was not able to establish when the procedure was changed. ( review on August 22, 2022 at 12:55 p.m. ) 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 verifications records reviewed ( year 2021- 2022) and laboratory general supervisor interview on August 22, 2022 , it was determined that the laboratory failed to perform at least ,every six months, the calibration verification procedures for the routine chemistry tests processed by the Selectra system. The findings include: 1. The laboratory uses Selectra system for routine chemistry tests ( lipid panel and glucose test ). 2. Review of routine chemistry calibration verification records from January 2021 to August 2022, showed that the laboratory did not perform the calibration verification procedures for routine chemistry tests schedule for December 17, 2021. No calibration verification procedures were performed during year 2022 neither. ( review on August 22, 2022 at 1:35 p.m. ) 3. The laboratory reported and processed 15 proficiency samples for routine chemistry subspecialty in 2022. ( review on August 22, 2022 at 1:38 p.m. ) 4. The laboratory general supervisor confirmed on August 22, 2022 at 1:45 p.m., that the laboratory failed to perform at least six months the calibration verification procedures for routine chemistry tests perform by the Selectra system since June 17, 2021. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or -- 3 of 6 -- produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: 1. Based on bacteriology quality control records review (year 2021-2022) and interview with the laboratory general supervisor on August 22, 2022 , it was determined that the laboratory failed to check each batch of culture media plates for sterility. The finding includes: a. The bacteriology quality control records showed that the laboratory did not check for sterility the following Blood Agar / Mc Conkey biplate agar media received during year 2021-2022: lot numbers - 479211, 483015, 485727, 488138P, 489418, 492447, 494189, 496308, 499811, 502427, 504410, 507360, 508553 and 509398P. ( review on August 22, 2022 at 12:30 p.m. ) b. The records showed that the laboratory did not check for sterility the following chocolate agar media plate received during year 2021: lot numbers - 499354 and 495836. ( review August 22, 2022 at 12:40 p.m. ) c. The laboratory reported and performed a total of 510 urine culture, 50 throat culture in 2021 and 227 urine culture and 34 throat culture in 2022. d. The laboratory general supervisor confirmed on August 22, 2022 at 12:50 p.m. that the laboratory failed to check each batch of Blood Agar / Mc Conkey biplate and chocolate culture media plates for sterility. 2. Based on bacteriology quality control records review (years 2021-2022) and interview with the laboratory general supervisor on August 22, 2022 , it was determined that the laboratory failed to check each lot of Blood Agar / Mc Conkey biplate and chocolate culture media plates for its ability to support growth. The finding includes: a. The laboratory performed urine colony count tests and performed primary inoculation on blood and Mac Conkey biplate agar. b. Review of bacteriology quality control records showed that the laboratory did not check the ability to support growth of the following lot numbers of BA / Mc Conkey biplate agar media used by them since February 25, 2021: 479211, 483015, 485727, 488138P, 489418, 492447, 494189, 496308, 499811, 502427, 504410, 507360, 508553 and 509398P. ( review August 22, 2022 at 12:45 p.m. ) c. Review of bacteriology quality control records showed that the laboratory did not check the ability to support growth of the following lot numbers of chocolate agar used by them since August 21, 2021: 499354 and 495836 ( review August 22, 2022 at 12:47 p.m. ) d. The laboratory processed 737 urine culture and 84 throat culture patient's samples from January 2021 to August 22, 2022. ( review August 22, 2022 at 12:48 p.m. ) e. The laboratory general supervisor confirmed on August 22, 2022 at 12: 50 p.m. that the laboratory failed to check each batch of Blood Agar / Mc Conkey biplate and chocolate culture media plates for its ability to support growth. 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 bacteriology quality control records review ( year 2021-2022 ) and laboratory general supervisor interview on August 22, 2022 at 2:10 P.M., it was determined that the laboratory director failed to fulfill his responsibilities and duties to ensure compliance with the bacteriology quality control requirements. The finding -- 4 of 6 -- includes: 1. The laboratory director did not ensure quality control procedures for bacteriology were implemented and followed. Refer to D6093 D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require